Balloon Tamponade Vs B-Lynch In Placenta Previa

NCT05133167 | Completed

• 1 other identifier: 16112021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients were allocated to group A and B. In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

• Mean blood loss

  Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

  24 hours post procedure

Study Arms (2)

GROUP A

EXPERIMENTAL

In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage.

Procedure: Balloon Tamponade or B-Lynch

GROUP B

EXPERIMENTAL

In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage.

Procedure: Balloon Tamponade or B-Lynch

Interventions

Balloon Tamponade or B-Lynch PROCEDURE

In group A, balloon tamponade (using Foley catheter 28 Fr) was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by measuring the amount of blood collected in Foley balloon tamponade bag, in milliliters. In group B, B lynch suture was used intra-operatively to prevent post-partum hemorrhage. Post-operative blood loss within first 24 hours was estimated by the weight difference of the pads before and after patient use (1-gram weight difference = 1 ml blood volume lost). Mean blood loss within first 24 hours post procedure, was compared in both the groups for outcome measurement.

GROUP A; GROUP B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy
• Late Third Trimester pregnancy (35+ weeks to 39 weeks)
• Placenta Previa confirmed by ultrasonography
• Elective Caesarean Section.

You may not qualify if:

• Multiple gestation
• Placenta accreta Spectrum (accrete/increta/percreta)
• Bleeding diathesis
• Other Causes of Post-Partum Hemorrhage i.e. Uterine atony, Genital tract tears, Retained Products of Conception etc.
• Serious medical or surgical diseases.

Sponsors & Collaborators

• CMH Jhelum: lead

Study Sites (1)

CMH

Jhelum, Punjab Province, 49600, Pakistan

Location

MeSH Terms

Conditions

Placenta Previa

Interventions

Balloon Occlusion

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endotamponade; Hemostatic Techniques; Embolization, Therapeutic; Therapeutic Occlusion; Investigative Techniques

Study Officials

• Muhammad Awais Qarni

  Anesthesiologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 24, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)